In recent years obesity and related disorders, such as diabetes and atherosclerotic cardiovascular disease, have increased substantially. When compliance with diet, exercise and behavioral therapy fail to achieve weight loss, pharmacotherapy may be instituted. However, pharmacotherapy has had only modest success and may be discontinued if a patient experiences unpleasant side-effects. Long term safety of pharmaceutical use for treatment of obesity is uncertain, and patients generally regain lost weight when the therapy is discontinued. A variety of surgical treatments have recently become available for obesity, but typically as a last resort. These surgical treatments have the advantage of more rapid initial weight loss and remission of diabetes mellitus than other non-invasive therapies. However, surgery is expensive, subject to risks of morbidity and mortality, and its efficacy may be reduced by patient noncompliance with post-surgical dietary restrictions. If patients fail to limit food intake, their bodies may undergo compensatory anatomical changes that partially overcome the effects of surgery. The most invasive surgical procedures tend to achieve the greatest long term percent change in weight, but also tend to be the most costly, require longer periods of recuperation and careful long term management of nutrients to avoid malnutrition.
There have been attempts to achieve the benefits of surgery using minimally invasive procedures that employ various medical devices. Current medical device therapy for obesity and metabolic disease includes insertion of tubular prosthetic barrier devices into the stomach and/or small intestine. However, these bariatric sleeve devices are generally inserted surgically or endoscopically, and any modification or removal necessitates additional surgical or endoscopic procedures. Bariatric sleeve devices generally consist of a floppy, elongated tube that is attached at the proximal end to a portion of the stomach or small intestine by suturing or use of a barbed anchor. The sleeve extends distally into at least a portion of the small intestine. Consumed food passes into and through the tube, which prevents absorption by adjacent portions of the small intestine.
These devices are generally anchored at the proximal end by a metal cage structure which is placed in a portion of the stomach or duodenum. Such attachments are near the proximate end of the device and subject to movement allowing seepage of nutrients and overall ineffectiveness of the device. Peristalsis in the small intestine generally makes similar anchoring of the device at the distal end difficult or impossible. In the small intestine, the uncontrolled distal end is subject to displacement by peristaltic contractions, which may contribute to observed distal migration or proximal invagination. These problems serve to limit sleeve length, and the corresponding effectiveness of the device. Bariatric sleeves are constructed of an impermeable material in order to effectively prevent absorption of food through the sleeve. However, this construction also prevents absorption of some nutrients, which necessitates patient supplementation with vitamins and minerals in order to avoid malnutrition. However, such supplementation is difficult because orally administered supplements may be blocked from absorption by the impermeable sleeve. Alternate methods, such as intravenous administration, are invasive and generally cannot be self-administered.
Thus, there is a need for a system and method for the treatment of obesity that may be easily inserted, positioned, modified and removed from a patient using minimally invasive techniques, that includes a shape-retaining structure to facilitate placement and to avoid collapse and displacement, that provides distal control to avoid forward and distal migration and proximal invagination or eversion, as well as preventing rotation or twisting at points along the sleeve and that provides for easy delivery, effective absorption, and control of nutritional supplements.